soft shapeable adhesive paste

ABSTRACT

The present invention relates to a pressure sensitive paste composition for skin application. The paste comprises 10-50% (w/w) based on the total paste formulation of a blend of polar polyethylene copolymer(s) and polar oil.

FIELD OF THE INVENTION

The invention relates to a soft and easy shapeable paste composition,which can be used for sealing between a stoma and a skin barrier.Furthermore, the composition can be used for smoothing out an irregularskin area for subsequent secure attachment of a skin barrier.

BACKGROUND OF THE INVENTION

In connection with surgery for a number of diseases in thegastro-intestinal tract a consequence is in many cases, that the colon,the ileum or the urethra has been exposed surgically. The patient isleft with an abdominal stoma and the effluents or waste products of thebody, which are conveyed through these organs, are discharged throughthe artificial orifice or opening and are collected in a collection bag.The bag is usually adhered to the skin by means of an adhesive wafer orplate having an inlet opening for accommodating the stoma.

Often a paste is used for filling an area between the stoma and the skinbarrier in order to provide a safe seal, or building up an irregularabdominal skin area around the stoma to achieve a smooth surface ontowhich an appliance can be securely attached.

Such pastes should have a composition which makes it sufficiently tackyto attach safely to the skin on an immediate basis, easily shaped byfinger pressure, and removable in one piece without leaving residues.Furthermore, the composition should be skin friendly, have a highmoisture absorption level and a high erosion resistance in order not toexpose the skin to exudates from the stoma.

Ostomy pastes are commercially available in the form of sticks/strips orrings, for example Coloplast ostomy paste, Eakin® ring, Stomahesive©paste marketed. International Publication No. WO 98/17329 describes amouldable mass of hypoallergenic, substantially non-memory putty-likeadhesive for use in connection with fistulas or ostomy appliances. Thecomposition comprises 1-20 wt. % of a block copolymer having a majorcontent of di-block copolymer, 5-60 wt. % of a tackifying liquidconstituent and 1-10 wt. % of a waxy constituent.

Eakin Cohesive®, a hydrocolloid product available from TG Eakin Limitedis said to be a mouldable, easily shaped, moisture absorbing skinbarrier. According to information extracted from the Eakin website,http://www.eakin.co.uk, it can be stretched, compressed or moulded tofit the exact shape and size as required. Eakin Cohesive contains noactive ingredients but is said to contain a unique carbohydrate which isslowly released while the seal is in place, diluting harmful enzymes,and protecting the skin against body wastes and fluids such as bile andileal fluid. The product can be used as a seal under stoma pouches andappliances, as a packing agent in skin folds and scars, as a seal arounddrain tubes and fistulae, and as a “picture frame” around wound edgesprior to dressing application.

These pastes suffer from two essential drawbacks:

1. In order not to remember its original shape (non-memory), the pasteshave a high level of plasticity. However, after use it is desirable tobe able to remove the pastes in one piece without leaving a large amountof, hard to cleanse, residues on the skin. For that reason a high volumeof particles in the form of hydrocolloids are added not only in order toachieve the desired moisture absorption rate and capacity, but also tomake the shape of the pastes stabile during use and minimise residueleft on the skin after removal. The high volume of particles makes thepaste harder, and for end-users it requires a certain amount offinger/hand strength. It is often time consuming to shape the pastes tofit the skin.2. The pastes have high moisture absorptions in order to achieve optimumadhesive performance and maintain a healthy skin. However, the necessaryabsorption level combined with the level of plasticity needed for thepastes to be non-memory like, means that it will disintegrate easily dueto the swelling of the hydrocolloids when in contact with exudates. Thepoor erosion resistance makes the service life short, promotes leakageand/or makes the skin of the users exposed to contact with aggressiveoutput, leading to skin issues.

As a method of improving the erosion resistance of hydrocolloidadhesives the use of cross-linked hydrocolloids is described.Cross-linked hydrocolloids (for example carboxymethyl cellulose (CMC),dextrane) will not dissolve due to the cross-linked structure. Duringthe swelling process, the individual particles will therefore obtain agel like structure, but no coherent gel can be formed since molecules inthe cross-linked materials are locked in a network constitutingindividual particles. However, in contact with exudates, thecross-linked hydrocolloids will be leached out due to the lack of acohesive gel, and the effect on the erosion resistance is thereforelimited.

Another method is increasing the cohesion of the continuous phase.Thereby the continuous phase will be less prone to disintegration duringthe swelling of the hydrocolloids. The drawback of utilising this methodis that the increased cohesiveness will reduce the absorption rate, andultimately a deficiency in plastic deformation will make the paste losecontact with the skin and exposing it, due to excessive swelling in thecontact with exudates.

It has now surprisingly been found that by utilising a soft permeablecomposition, a paste can be produced that is easier to shape and hasimproved erosion resistance, without compromising the moistureabsorption, ease of removal or introducing other possible adverseeffects.

SUMMARY OF THE INVENTION

The present invention relates to a pressure sensitive paste compositionfor skin application. The paste comprises 10-50% (w/w) based on thetotal paste formulation of a blend of polar polyethylene copolymer(s)and polar oil.

DETAILED DESCRIPTION OF THE INVENTION

The soft permeable composition used is a polar polyethylene copolymercomprising a polar plasticizing oil such as described in InternationalPatent Application No. WO2009/006901. The compositions described inInternational Patent Application No. WO2009/006901 are hot meltprocessable comprising more than 10% (w/w) of polar plasticizing oil anda content of 10-50% of polyethylene copolymer(s) with a melt flow indexbelow 2 g/10 min (190° C./21.1N).

These soft permeable compositions are themselves not suited forpreparing an ostomy paste due to the high molecular weight of thepolyethylene vinyl copolymers. A paste made entirely of these materialswould either have to be so soft that it would be impossible to handleduring use, or it will have too high a level of elastic properties for apaste to sustain the desired form after the shaping procedure. However,when these materials are mixed with traditional paste compositions,favourable rheological properties are surprisingly achieved.

In one embodiment of the invention, the pressure sensitive pastecomposition for skin application comprises 10-50% (w/w) based on thetotal paste formulation of a blend of polar polyethylene copolymer(s)and polar oil.

By introducing a soft highly permeable polyethylene copolymercomposition in the otherwise non-permeable continuous phase it ispossible to achieve a softer paste either by using a lower amount ofhydrocolloids and/or by increasing the cohesiveness and softness of thepaste without lowering moisture absorption rate or introducing thefailure modes that are normally related to the elastic properties of thepaste (tensions in the shaped paste, excessive swelling in contact withbody fluids).

For the end-user, these improvements mean that it is much easier (orpossible) to shape the paste to the desired form. Some users couldpossibly do the shaping directly on the abdominal skin, therebyachieving a safer seal between the stoma and the adhesive base plate ora more secure attachment of the base plate over skin irregularities. Theincreased erosion resistance of the pastes will also add to the safetyof the users, as erosion often promotes leakage. Furthermore, skincontact with aggressive body exudates has proven to be the major causeof skin problems for people with an ostomy. The erosion resistance ofthis new type of paste will significantly minimise the exposure of theperistomal skin during use, and help maintain a healthy skin.

Combining thermoplastic materials that are highly permeable andnon-polar materials (continuous phase) respectively, could causestability issues due to phase separation or migration. However, ageingstudies have proven that these compositions according to the inventionhave the desired stability with respect to water absorption, adhesionand rheological properties. Dynamic mechanical analysis shows uniformcurves of IG*I and tan(δ) with a combined rheological expression of boththe non-polar and the highly permeable part.

In one embodiment of the present invention, the blend of polarpolyethylene copolymer(s) and polar oil comprises a polar plasticizingoil or a combination of polar plasticizing oils in the content of above10% (w/w) of the blend, the content of the polyethylene copolymer(s) is10-50% (w/w) of the blend, and at least one polar polyethylene copolymerhas a melt flow index below 2 g/10 min (190° C./21.1N).

The blend may be mixed with any conventional paste or mouldable adhesivesuch as the ones described in International Publication Nos. WO 98/17329and WO 98/17212.

In another embodiment of the present invention, the blend of polarpolyethylene copolymer(s) and polar oil comprises a polar plasticizingoil or a combination of polar plasticizing oils in the content of above10% (w/w) of the blend, the content of the polyethylene copolymer(s) is10-50% (w/w) of the blend, and the polar polyethylene copolymer(s) has amelt flow index below 2 g/10 min (190° C./21.1N).

In an embodiment of the invention, the final paste in continuous formexhibits a moisture vapour transmission rate of at least 150 g/m²/24hours, preferably at least 200 g/m²/24 hours for a 1 mm sheet whenmeasured according to MVTR test method.

According to one embodiment of the invention, the final paste has acomplex modulus |G*| of less than 1,000,000 Pa, preferably less than250,000 Pa at 1 Hz (1% deformation, 32° C.).

According to one embodiment of the invention, the final paste has atan(δ) above 0.9, preferably above 1.0 at 1 Hz (1% deformation, 32° C.).

The primary polymers used in the blend are polyethylene copolymers. Thecopolymer should contain a considerable amount of a polar component toget high water permeability.

In one embodiment of the invention, the polar polyethylene copolymer isselected from the group consisting of ethylene vinyl acetate, ethylenevinyl acetate carbon monoxide, ethylene butyl acetate, ethylene vinylalcohol, ethylene butyl acrylate, ethylene butyl acrylate carbonmonoxide, and combinations thereof.

The polar polyethylene copolymer is preferably ethylene vinyl acetate.

By polar polymers is meant polymers with water transmission above 50g/m²/day for a 150 μm film when measured according to the MVTR testmethod.

In an embodiment of the invention, the ethylene vinyl acetate has acontent of at least 40% (w/w) vinyl acetate preferably with 40-80% (w/w)vinyl acetate.

Preferably, the polar polyethylene copolymers used in the paste shouldhave a molecular structure at a level that results in a melt flow index(MFI) below 2 g/10 min (190° C./21.1N). The melt flow index can bemeasured by the methods given in ISO 1133 and ASTM D1238.

The advantage of using a polymer with high molecular weight and low MFIis that the high molecular weight polymer can ensure a sufficient highcohesive strength to the paste.

By the content of the final paste is meant the percentage in weight ofthe ingredient in relation to the total weight of the ingredients usedin the paste composition.

In an embodiment of the invention, the content of the polar polyethylenecopolymer(s) is 5-20% (w/w) of the final paste.

In another embodiment of the invention, the polar polyethylenecopolymer(s) has a molecular weight above 250,000 g/mol.

In one embodiment of the present invention, the paste compositioncomprising a polar plasticizing oil or a combination of polarplasticizing oils in the content of 5-40% (w/w) of the final paste.

In one embodiment of the present invention, the paste compositioncomprising a polar plasticizing oil wherein the polar plasticizing oilis selected from the group of liquid rosin derivatives, aromatic olefinoligomers, vegetable and animal oils and derivatives. Preferable polaroils are esters, ethers and glycols.

Particularly preferable oils are poly propylene oxides such asalpha-butoxy-polyoxypropylene. Polypropylene oxide oil contributes to ahigh permeability of the paste composition.

Some of the paste compositions according to the invention contain aminor amount of additional polar polymer in the blend besides the mainpolymer adding cohesion. This or these additional polymers are added togive tack. These additional polymers are optional and not necessary forall purposes.

In one embodiment of the invention, the paste composition furthercomprises a low molecular weight polar polymer, that is MFI>2.

The addition of a low Mw polymer to the paste may be an advantage when alot of moisture is present between the paste and the skin.

Additional components may be added to the composition such as tackifierresin.

In one embodiment of the invention, the paste composition furthercomprises a tackifier resin such as natural, modified or syntheticresins preferably polar resins such as rosins, rosin esters,hydrogenated rosins, hydrogenated rosin esters, and derivatives of suchpolar resins or pure aromatic monomer resins.

Tackifier resins can be added to control tack in the paste, that isreduce moduli and increase glass transition temperature.

The content of the tackifier resin is 0-20% (w/w) of the final paste.Preferably the paste is substantially free of resin. When the pastecomposition contains resin, the content of the tackifier resin ispreferably 0.1-20% (w/w) of the final paste.

In another embodiment of the invention, the paste composition furthercomprises other ingredients selected from the group of antioxidants,stabilisers, fillers, pigments, flow modifiers, and active ingredients.

In one preferred embodiment of the invention, the paste compositioncomprises polar active ingredients.

According to an embodiment of the invention, the composition furthercomprises absorbing particles such as hydrocolloid.

As with traditional hydrocolloid adhesives and pastes, most liquidabsorbing polymeric particles can be used, including microcolloids.

More particularly, the hydrocolloids may be guar gum, locust bean gum(LBG), pectin, alginates, potato starch, gelatine, xanthan, gum karaya;cellulose derivatives (e.g. salts of carboxymethylcellulose such assodiumcarboxymethylcellulose, methylcellulose, hydroxyethyl celluloseand hydroxypropylmethylcellulose), sodium starch glycolate,polyvinylalcohol and/or polyethylene glycol.

In one embodiment of the invention, the content of hydrocolloid is20-60% (w/w) of the total composition.

Microcolloid particles are well known in the art, for example fromInternational Publication No. WO 02/066087, which discloses adhesivecompositions comprising microcolloid particles. The microcolloidparticles may have a particle size of less than 20 microns.

In one embodiment of the invention, the pressure sensitive pastecomposition comprises based on the total formulation 1-10% (w/w) of ablockcopolymer having a major content of di-block, 10-35% (w/w) of atackifying liquid constituent, and 1-8% (w/w) of a waxy constituent.

By a major content of di-block is meant that the content of di-block inthe blockcopolymer is above 25% (w/w), preferably above 30% (w/w), andmore preferably above 50% (w/w) of the total amount of blockcopolymer.

According to one embodiment of the invention, the pressure sensitivepaste composition comprises, based on the total formulation 1-10% (w/w)of a blockcopolymer having a content of di-block above 30%, 10-35% (w/w)of a tackifying liquid constituent, and 1-8% (w/w) of a waxyconstituent.

According to an embodiment of the invention, the pressure sensitivepaste composition comprises, based on the total formulation 5-25% (w/w)polar polyethylene copolymer, 5-40% (w/w), of a polar oil, 1-10% (w/w)of a blockcopolymer having a major content of di-block, 10-35% (w/w) ofa tackifying liquid constituent, 1-8% (w/w) of a waxy constituent, and20-60% (w/w) hydrocolloids.

The blockcopolymer may be a copolymer comprising a block of a relativelyhard polymer which may form physical cross-linking and a block of asofter polymer. The constituents of the blockcopolymer may be the sameas are conventionally used for blockcopolymers such as SBS, SIS or SEBScopolymers, for example styrene and butadiene, isoprene orethylenebutylene copolymers. The preferred copolymer is astyrene-ethylenebutylene-styrene copolymer (SEBS) having a content ofdi-block component above 30%.

The tackifying viscous liquid constituent is preferably a viscouspolymeric material being compatible with the blockcopolymer. Thetackifying liquid may be a polybutylene or polyisobutylene. Themolecular weight of a tackifying viscous polymeric component ispreferably from 10,000 to 120,000 when determined by GPC.

The waxy component may for example be a mineral wax or petroleum jelly,however, preferably a microcrystalline wax that is compatible with thepreferred block copolymer SEBS.

The invention also relates to medical devices comprising a pressuresensitive paste composition as described above.

The medical device comprising a paste composition according to theinvention may be an ostomy appliance, a device for collecting urine or afaecal management device.

Experimental Laboratory Methods Method 1: Mixing

The adhesives were compounded in an Aoustin mixer MX 0.4 (contains about200 grams), from F. Aoustin et Cie, 11 Rue de Préaux 76161 Darnetal,France.

The chamber temperature in the mixer was approx. 90° C. and the adhesivewas compounded with 30-45 rpm.

Premix of the polar polyethylene copolymer and oil was added to themixer together with extra PPO, premix 2 and hydrocolloids. The compoundwas mixed for approx 30 min.

Method 2: Mechanical Degradation of Pre-Cross-Linked Levamelt

In some cases, it was necessary to perform a mechanical degradation ofthe pre-cross-linked EVA, for example when Levamelt 500 was used. Thepolymer was mixed for about 10 hours in a cold Hermann Linden LK II 0.5mixer to get mechanical breakdown of the polymer chains. The heatingsystem was not turned on and the mixing speed kept low, app. 20 rpm, toensure optimal mechanical work on the polymer. The breakdown of thepolymer was followed by visual inspection of a thermoformed film of thetreated polymer. The mechanical treatment was continued until only aminor amount of polymer gel-lumps remained.

Method 3: Gamma Irradiation

1 kilo of the polymer was placed in a plastic bag. The bag was packedand sent to the gamma irradiation supplier, for example BGS Beta-GammaService, Wiehl, Germany. The polymer was irradiated with the specifiedgamma dose, for example 30 kGy. The gamma radiation increases the molarweight of the polymer. When the polymer was returned, it was mixed withoil, to obtain pre-mixtures as described above.

Method 4: Determination of Moisture Absorption

Samples were prepared by thermoformed to an approx. 1±0.1 mm adhesivefilm between two release liners.

With a punching tool, samples were punched out. Sample size was 25×25mm. The release liners were removed. The samples were glued to an objectglass and placed in a beaker with physiological salt water and placed inan incubator at 37° C.

Calculation:

The sample was weighed over time (=M(10 min)).

For a 25×25 mm sample the area was 6.25 cm² (the surface edges were leftout of the area).

The moisture absorption may be calculated as:

${{water}\mspace{14mu} {{abs}.\mspace{14mu} {after}}\mspace{14mu} 2\mspace{14mu} {hours}} = {\frac{{M\left( {2\mspace{14mu} {hours}} \right)} - {M({start})}}{6,25}\mspace{14mu}\left\lbrack {g\text{/}{cm}^{2}} \right\rbrack}$

Method 5: Determination of Moisture Vapour Transmission Rate (MVTR)

MVTR was measured in grams per square meter (g/m²) over a 24 hour periodusing an inverted cup method.

A container or cup that was water and water vapour impermeable having anopening was used. 20 ml saline water (0.9% NaCI in demineralised water)was placed in the container, and the opening was sealed with the testadhesive film. The container was placed into an electrically heatedhumidity cabinet, and the container or cup was placed upside down suchthat the water was in contact with the adhesive. The cabinet wasmaintained at 37° C. and 15% relative humidity (RH). The weight loss ofthe container was followed as a function of time. The weight loss wasdue to evaporation of water vapour transmitted through the adhesivefilm. This difference was used to calculate Moisture vapour transmissionrate or MVTR. MVTR was calculated as the weight loss per time divided bythe area of the opening in the cup (g/m²/24 h). The MVTR of a materialwas a linear function of the thickness of the material. Thus, whenreporting MVTR to characterise a material, it was important to informthe thickness of the material which MVTR was reported. We used 1.0 mm asa reference. If thinner or thicker samples were measured, the MVTR wasreported as corresponding to a 1.0 mm sample.

Finally, we noted that by using this method, we introduced an error byusing a supporting PU film. The error was eliminated by utilising thefact that the adhesive/film laminate was a system of two resistances inseries. When the film and the adhesive were homogeneous, thetransmission rate may be expressed as:

1/P(measured)=1/P(Film)+1/P(Adhesive)

Hence, by knowing the film permeability and thickness of the adhesive,it was possible to calculate the true permeability of the adhesive(P(Adhesive)) using the following expression:

P(adhesive)=d(Adhesive)/150 micron*1/(1/P(measured)−1/P(Film))

where d(Adhesive) was the actual measured thickness of the adhesive andP(Film) was the MVTR of the film with no adhesive, and P(measured) wasthe actual measured MVTR.

Method 6: Determination of Erosion Resistance

Samples were prepared by thermoforming a 2±0.1 mm adhesive plate betweentwo release liners. Said adhesive plate was transferred and laminatedwith a non-permeable foil on both sides.

With a punching tool round samples were punched out and placed in closedbeakers with physiological salt water and placed at room temperature(23° C.). The beakers were rotated to obtain dynamical mechanical stressof the sample at the same time as water absorption took place.

After 18 hours the eroded part was measured in mm in radial directionfrom the centre hole towards the outer periphery of the sample.

Method 7: Determination of Peel Failure Mode:

Peel failure mode was determined by peeling the sample from skin.

Peel failure mode, that is adhesive or cohesive failure of the adhesive,was visually observed. Cohesive failure was unwanted, as adhesives withcohesive failure were likely to leave residues on the substrate whenremoved.

The test samples were prepared by thermoforming an approximately 1±0.1mm adhesive film between two release liners. Said adhesive film wastransfer coated onto a 30 μm polyurethane film.

The test specimens were applied to the underside of the forearm and leftfor about 2 hours before they were peeled. The results were reported asAdhesive or Cohesive peel failure mode.

Method 8: Dynamic Mechanical Analysis (DMA) and Determination of G′ andtan(δ)

The parameters |G*| and tan(δ) were measured as follows: The adhesiveswere pressed into a plate of 1 mm thickness. A round sample of 25 mm indiameter was cut out and placed in a RheoStress RS600 rheometer fromThermo Electron. The geometry applied was parallel plates 25 mm and thedeformation was fixed at 1% to ensure that measurements were in thelinear regime. The measurements were carried out at 32° C.

Materials

Name Chemistry Supplier SIS Kraton G 1726 x Styrene block copolymerKraton Polymer Indopol H-18000 Polybutene AWL Kemi Aps Eastoflex Amorfpolyolefin Brøste Sasol micro wax PE-wax Sasol wax Levamelt 700 Ethylenevinyl acetate Lanxess copolymer Levamelt 500 Ethylene vinyl acetateLanxess copolymer Polyglycol B01/120 Poly Propylene oxide oil ClariantNatrosol 250HX Pharma Hydrocolloids Hercules Pektin Pomosin LM 12Hydrocolloids CP Kelco Aps Guar Gum Hydrocolloids Nordisk GelatineGelatin Hydrocolloids PB Gelatines Zink oxide Colourant HarcrosChemicals Inc

Pre-mix 2 Raw material [%(w/w)] Kraton G 1726 X 12.5 Indopol H-18000 75Eastoflex 6.25 Sasol micro wax 6.25 Total: 100.00 Table pre-mix strippaste [%(w/w)]

Results Example 1

Measured according to method 4, 5, 6, 7 and 8:

Moisture absorption, moisture vapour transmission rate (MVTR), erosionresistance, peel failure mode and DMA.

Sample number 065.01 065.02 #10 #11.B #12 #13 #14 #15 #27 Pre-mix 2 2721.5 30 28.9 28.5 28.5 27 63.5 30.25 Levamelt 700, 15 15 11 10.5 9.759.75 10.25 12.8 22KGy Levamelt 500, 2 1.5 1.5 17KGy Clariant B01/ 24.029.5 22.5 21.6 23.25 23.75 20.75 21.7 120 Polyglycol Total 66 66 63.5 6163.5 63.5 59.5 63.5 64.75 Natrosol 13 12.5 13 13 13 13 9 250HX PharmPektin 14 14 11.5 11 11.5 11.5 14.5 11.5 12 Pomosin LM 12 Cg-Z/200 GuarGum 3 3 3 3 3 3 Gelatine 20 20 8.5 12 8.5 8.5 9.5 8.5 14.25 Potatostarch ZnOx 0.5 0.5 0.5 0.5 0.5 0.5 Total, 34 34 36.5 39 36.5 36.5 40.536.5 35.25 hydrocolloid Moisture 0.026 0.036 0.14 0.13 0.15 0.15 0.150.16 0.13 absorbance, 2 hours g/cm² Transmission, 462 682 695 90 1 mmsample, g/m²/day Erosion, 0 0 0.2 0.2 0 0 0 3 0 borderline, mm Peelfailure Adhesive Cohesive Cohesive Cohesive Adhesive Adhesive AdhesiveCohesive Adhesive mode DMA, 8.87e+04 6.74e+04 8.96e+04 7.57e+04 1.15e+051.05e+05 1.31e+05 2.69e+05 1.2e+05 module |G*| 0.98 0.97 1.17 1.17 0.931.03 0.97 1.88 1.0 tan delta, 1 Hz

The polar polyethylene copolymer/PPO oil premixes are softer but moreelastic than the non-polar Pre-mix 2. Therefore, composition #10 to #14& #27 show a higher elasticity but a decrease in hardness with increasedaddition of the polar premixes as compared to #15 that only contains thenon-polar Pre-mix 2.

It can also be observed that the polar polyethylene copolymer and polarplasticizing oil compounded with the more plastic non-polar Pre-mix 2,results in more elastic compositions with low erosion and withoutcompromising the moisture absorption level due to the increased vapourtransmission.

The DMA results and Peel failure mode tests show that it is possible toproduce a paste with optimal adhesion and easy adaptability to skinirregularities and -folds and sufficient cohesive strength forsubsequent removing in one piece, such as #10-15 & 27 (adhesive peelfailure).

Compositions of Levamelt and PPO Oil with Pre-Mix 2

Sample number 066.01 066.02 066.04 066.06 #14 #27 Pre-mix 2 37 17 17 1727 30.25 Levamelt 700, 8.15 15.4 20.5 12.8 22KGy Levamelt 500, 42.5 317KGy Clariant B01/ 14.35 27.1 21.3 9 21.7 120 Polyglycol Levamelt 70021.3 Total 59.5 59.5 59.5 59.6 59.5 64.75 Natrosol 250HX 13 13 13 13 139 Pharm Pektin Pomosin 14.5 14.5 14.5 14.5 14.5 12 LM 12 Cg-Z/200 GuarGum 3 3 3 3 3 Gelatine 9.5 9.5 9.5 9.5 9.5 14.25 Potato starch ZnOx 0.50.5 0.5 0.5 0.5 Total, 40.5 40.5 40.5 40.5 40.5 35.25 hydrocolloidsTransmission, 587 814 1 mm sample, g/m²/day Peel failure mode AdhesiveAdhesive Adhesive Adhesive Adhesive Adhesive DMA, module 2.07e+05,1.16e+05, 7.62e+05, 2.64e+05, 1.15e+05, 1.2e+05 G*, tan delta, 0.99 0.800.54 0.87 0.93 1.0 1Hz,

For 066.02, .04 and 0.06 the deformation of the paste will not bepermanent due to the high level of elasticity.

066.01, #14 & #27 have however proven to work well as a paste. They areeasy to shape by finger pressure and can easily build up an irregularabdominal skin area, and can be used for joining a skin barrier toirregular abdominal skin.

1. A pressure sensitive paste composition for skin applicationcomprising 10-50% (w/w) based on the total paste formulation of a blendof polar polyethylene copolymer(s) and polar oil.
 2. The pressuresensitive paste composition according to claim 1, wherein the blend ofpolar polyethylene copolymer(s) and polar oil comprising a polarplasticizing oil or a combination of polar plasticizing oils in thecontent of above 10% (w/w) of the blend, the content of the polyethylenecopolymer(s) is 10-50% (w/w) of the blend, and at least one polarpolyethylene copolymer has a melt flow index below 2 g/10 min (190°C./21.1N).
 3. The pressure sensitive paste composition according toclaim 1, wherein the blend of polar polyethylene copolymer(s) and polaroil comprises a polar plasticizing oil or a combination of polarplasticizing oils in the content of above 10% (w/w) of the blend, thecontent of the polyethylene copolymer(s) is 10-50% (w/w) of the blend,and the polar polyethylene copolymer(s) has a melt flow index below 2g/10 min (190° C./21.1N).
 4. The pressure sensitive paste compositionaccording to claim 1, wherein the final paste in continuous formexhibits a moisture vapour transmission rate of at least 150 g/m²/24hours, preferably at least 200 g/m²/24 hours for a 1 mm sheet whenmeasured according to the MVTR test method.
 5. The pressure sensitivepaste composition according to claim 1, wherein the final paste has acomplex modulus |G*| of less than 1,000,000 Pa, preferably less than250,000 Pa at 1 Hz (1% deformation, 32° C.).
 6. The pressure sensitivepaste composition according to claim 1, wherein the final paste has atan(δ) above 0.9, preferably above 1.0 at 1 Hz (1% deformation, 32° C.).7. The pressure sensitive paste composition according to claim 1,wherein the polar polyethylene copolymer is selected from the groupconsisting of ethylene vinyl acetate, ethylene vinyl acetate carbonmonoxide, ethylene butyl acetate, ethylene vinyl alcohol, ethylene butylacrylate, ethylene butyl acrylate carbon monoxide, and combinationsthereof.
 8. The pressure sensitive paste composition according to claim7, wherein the polar polyethylene copolymer is ethylene vinyl acetate.9. The pressure sensitive paste composition according to claim 8,wherein the ethylene vinyl acetate has a content of at least 40% (w/w)vinyl acetate preferably with 40-80% (w/w) vinyl acetate.
 10. Thepressure sensitive paste composition according to claim 1, wherein thecontent of the polar polyethylene copolymer(s) is 5-20% (w/w) of thefinal paste.
 11. The pressure sensitive paste composition according toclaim 1, wherein the polar polyethylene copolymer(s) has a molecularweight of above 250,000 g/mol.
 12. The pressure sensitive pastecomposition according to claim 1, wherein the polar plasticizing oil isselected from the group of liquid rosin derivatives, aromatic olefinoligomers, vegetable and animal oils and derivatives, preferable polaroils being esters, ethers and glycols, and particularly preferable ispoly propylene oxide such as alpha-butoxy-polyoxypropylene.
 13. Thepressure sensitive paste composition according to claim 1, wherein theration of polar polyethylene copolymer and polar oil is between 1:1 and1:3.
 14. The pressure sensitive paste composition according to claim 1,wherein the composition further comprises a polar polymer with MFI>2(190° C./21.1N).
 15. The pressure sensitive paste composition accordingto claim 1, wherein the composition further comprises a tackifier resinsuch as natural, modified or synthetic resins, preferably polar resinssuch as rosin esters and derivatives thereof or pure aromatic monomerresins.
 16. The pressure sensitive paste composition according to claim15, wherein the content of the tackifier resin is 0.1-20% (w/w) of thefinal paste.
 17. The pressure sensitive paste composition according toclaim 1, wherein the composition further comprises other ingredientsselected from the group of antioxidants, stabilisers, fillers, pigments,flow modifiers, and active ingredients.
 18. The pressure sensitive pastecomposition according to claim 1, wherein the composition furthercomprises absorbing particles such as hydrocolloid.
 19. The pressuresensitive paste composition according to claim 18, wherein the contentof hydrocolloid is 20-60% (w/w) of the total composition.
 20. Thepressure sensitive paste composition according to claim 1, wherein thecomposition comprising based on the total formulation 1-10% (w/w) of ablock copolymer having a major content of di-block, 10-35% (w/w) of atackifying liquid constituent, and 1-8% (w/w) of a waxy constituent. 21.The pressure sensitive paste composition according to claim 1, whereinthe composition comprising based on the total formulation 5-25% (w/w)polar polyethylene copolymer, 5-40% (w/w) of a polar oil, 1-10% (w/w) ofa block copolymer having a major content of di-block, 10-35% (w/w) of atackifying liquid constituent, 1-8% (w/w) of a waxy constituent, and20-60% (w/w) hydrocolloids.
 22. A medical device comprising a pressuresensitive paste composition according to claim
 1. 23. The medical deviceaccording to claim 22, wherein the medical device is an ostomyappliance, a urine collecting device or a faecal management device.